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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003749-42 |
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The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.
Different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations actively unadvisable.
Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT. Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned.
Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir + lamivudine does not detract from the potency of HAART, the toxicity profile is different and their behaviour at mitochondrial level is similar.
This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Maintain antiretroviral treatment | |
| 2 | Experimental | Change tenofovir to abacavir and increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg. |
|
| 3 | Experimental | Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir | Drug | Change tenofovir to abacavir |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline. | At 12, 24, 36 and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period. | At 12, 24, 36 and 48 weeks. | |
| Incidence of new clinical adverse events that appear . | during 48 weeks of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enric Pedrol, MD, PhD | Fundació Hospital de Granollers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de la Santa Creu i Sant Pau |
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| Didanosine |
| Drug |
Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg. |
|
|
| Abacavir+Lamivudine | Drug | Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet). |
|
|
| Evolution of the clinical adverse events that were already present at the time they were included in the study. | during the 48 weeks of follow-up |
| Rate of treatment drop-outs due to the appearance of adverse events | during the 48 weeks of follow-up |
| Incidence of new laboratory alterations that appear during the follow-up period (change in renal parameters, changes in lactate levels, modification of pancreatic enzymes, changes in lipid parameters). | during the follow-up period |
| Evolution of the laboratory alterations that were already present at the time they were included in the study. | during the 48 weeks of follow-up |
| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital Clínic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Sant Jaume de Calella | Calella | Barcelona | 08370 | Spain |
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
| Hospital Basurto | Bilbao | Bilabao | 48013 | Spain |
| Hospital Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Sierrallana | Torrelavega | Cantabria | 39300 | Spain |
| Hospital General de Castellón, , Castellón, | Castelló | Castello | 12004 | Spain |
| H. del S.A.S. Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11407 | Spain |
| H. San Fco Borja Gandia | Gandia | Gandia | 46700 | Spain |
| Hospital de Cabueñes | Gijón | Gijon | 33394 | Spain |
| Hospital Clínico San Cecílio | Granada | Granada | 18012 | Spain |
| Fundació Hospital de Granollers, | Barcelona | Granollers | 08400 | Spain |
| Hospital Arquitecto Marcide | Ferrol | La Coruña | 15405 | Spain |
| Fundación Jiménez Diaz | Madrid | Madrid | 28040 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Virgen Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Joan XXIII | Tarragona | Tarragona | 43007 | Spain |
| Hospital Arnau de Vilanova | Valencia | Valencia | 46015 | Spain |
| Hospital Xeral de Vigo | Vigo | Vigo | 36204 | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C106538 | abacavir |
| D016049 | Didanosine |
| C492871 | abacavir, lamivudine drug combination |
| ID | Term |
|---|---|
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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